Injection device with pricking protection and/or overload protection for a product container

ABSTRACT

An injection device having a distal end, and including a needle located inside the injection device in an initial position, wherein the needle is moveable to a puncturing position in which the needle projects from the distal end, an open region located distally relative to the needle in the initial position of the needle and having a dimension, a reduction piece moveable relative to the opening region whereby the dimension may be reduced and a holding member that latchingly connects to the reduction piece and a product container holder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/305,358 filed Nov. 28, 2011, issued as U.S. Pat. No. 8,945,053 onFeb. 3, 2015, which is a continuation of International PatentApplication No. PCT/EP2009/056690 filed May 29, 2009, the contents ofwhich are hereby incorporated by reference.

BACKGROUND

The present application relates to devices for injecting, delivering,administering, infusing or dispensing a substance, and to methods ofmaking and using such devices. More particularly, it relates to aninjection device for administering a product, e.g. a drug. In someembodiments, it relates to automatic injection devices, although it isnot limited to such devices.

Automatic injection devices, which may be referred to as auto-injectors,are known from the prior art. Such devices provide for automaticdelivery of a substance or product. A needle associated with suchdevices can be injected manually or automatically. If the needle ismanually injected or inserted into a patients or users body, theinjection movement of the needle is imparted by a user's hand, forexample by the user grasping the injection device and pressing it ontoan injection point, thus injecting the needle. If the needle isautomatically injected, the injection movement of the needle isgenerated by a drive member, such as a spring element, which advancesthe needle into the injection point.

Such injection devices can comprise an opening from which the needle canbe extended manually or automatically. There are devices in which theopening exhibits a diameter only slightly larger than the needle, suchthat accessing the needle, for example with a finger, and thusinadvertently pricking oneself is prevented. In these devices, however,the ability to assemble the injection device may be affected orrestricted. There are also devices in which the opening is dimensionedlarge enough to facilitate assembly of the device, but in these devices,the opening is generally large enough that a finger can fit into orthrough it, thus incurring the danger of an inadvertent needle stick orpricking.

Injection devices which accommodate a product or substance container,e.g. an ampoule, carpoule, vial, etc., containing a product to bedelivered are also known. A needle can be attached to the distal end ofthe product container. In some instances, the proximal end of theproduct container, i.e. the end opposite the needle, is fastened to theinjection device. Due to the forces which arise when an injection deviceis used, the product container may be released and/or separated from theinjection device or, in more extreme cases, the container may break,thus enabling it to fall out of the injection device.

SUMMARY

An object of the present invention is to provide an injection device inwhich the danger of an inadvertent needle stick or pricking is reducedor eliminated, yet the injection device remains convenient to assemble.(Any reference to “the invention” or “the present invention” in thisapplication shall not be construed as a generalization, limitation orcharacterization of any subject matter disclosed herein and shall not beconsidered to be an element or limitation of the appended claims exceptif and/or where explicitly recited in a claim(s). Another object of thepresent invention to provide an injection device in which the productcontainer is prevented from falling out of the device.

In one embodiment, an injection device in accordance with the presentinvention comprises a distal end, a needle located inside the injectiondevice in an initial position, wherein the needle is moveable to apuncturing position in which the needle projects or extends from thedistal end of the device, an opening region relative to the needle inthe initial position of the needle and having a dimension, and areduction piece moveable relative to the opening region whereby thedimension may be reduced. In some embodiments, the opening region islocated distally relative to the needle in the initial position of theneedle.

In some embodiments, the present invention relates to an injectiondevice for administering a product, e.g. a liquid or fluid product orsubstance such as a medicinal or therapeutic substance. The product orsubstance can be stored in a product container in liquid form or inliquid and solid form. In the latter case, the product container may bereferred to and/or thought of as a bicameral or multi-chambered productcontainer in which a liquid active agent is mixed with a solid orpowdery active agent directly before administering. The injection devicecan be designed for manual or automatic injecting. In some preferredembodiments, the injection device is an automatic device, which may bereferred to and/or thought of as an auto-injector.

In one aspect of the present invention, the injection device comprises adistal end and a needle, wherein the needle is situated within theinjection device in an initial position or condition and can be moved toan injection position in which it protrudes or extends beyond the distalend of the injection device. The needle is situated in its initialposition in the injection device as sold, shipped or otherwise providedto a user. In the injection position, the needle protrudes beyond thedistal end of the injection device to an extent which approximatelycorresponds to the injection depth of the needle into and/or through theskin at the injection point. The distal end of the injection device isdesigned to be pressed onto and/or around the injection point. Theneedle can be fixedly connected to the product container, such as whenthe product container is manufactured. In this embodiment, the productcontainer can also be referred to as a syringe and its proximal end cancomprise a flange by which the syringe can be fastened in the injectiondevice. Alternatively, the needle can be fastened, as a separate part,to the product container. The product container may be referred to as acarpoule or ampoule. The proximal end of the carpoule, ampoule andsyringe may, but need not necessarily, comprise a flange for fastening,which is sometimes referred to as a finger flange.

In some embodiments, an injection device in accordance with the presentinvention comprises an opening region which is situated distally withrespect to the needle and/or the needle tip, when the needle is in itsinitial position, wherein the opening region exhibits a dimension, e.g.a cross-section. When the needle is in its initial position, the openingregion can extend between the needle and/or needle tip and the distalend of the injection device. The needle tip is to be understood to meanthe distal end region of the needle. The opening region can besurrounded laterally, i.e. around the longitudinal axis of the needle,by a housing or a triggering element, e.g. in the shape of a sleeve. Theopening region can exhibit a cross-section, i.e. a cross-sectional area,which is approximately normal to the longitudinal axis of the needle.The cross-section is delineated by the structure or structuralelement(s) which immediately surrounds the cross-section. The openingregion may exhibit a constant or a varying cross-section over itsoverall axial length. If an opening region comprises a number ofcross-sections of different areas, it should be understood that, in someembodiments, it is the smallest cross-section that is being referred towhen a cross-section is mentioned.

In some embodiments, an injection device in accordance with the presentinvention comprises a movable reducing piece. The reducing piece can bemoved into the opening region, e.g. from a position which does not liein the opening region. The movement may be directed along thelongitudinal axis, e.g. parallel to the longitudinal axis, transverse tothe longitudinal axis, or transverse to and along the longitudinal axisin combination. The movement of the reducing piece into the openingregion reduces the cross-section of the opening region. The reducingpiece can reduce the cross-section of the opening region at the point atwhich it is arranged in the opening or open region. The reducing piecemay comprise an opening which exhibits a cross-section smaller than thecross-section of the opening region at the point at which the reducingpiece is arranged in the opening region. The cross-section of theopening region in the region of the reducing piece may be dimensionedsuch that the needle can be moved through the opening region despite thereducing piece arranged in the opening region.

Structure, features and function in accordance with the presentinvention reduce the size of the opening or open region such thataccessing the needle through the opening, for example with a finger, isno longer possible. This reduces the danger of inadvertent sticks orpricking, as well as reduces the chance of contaminating the needle.

In some preferred embodiments, an injection device in accordance withthe present invention comprises a removing element, e.g. in the form ofa cap, which is removably arranged on the injection device, e.g. on itsdistal end. The removing element prevents access to the needle in theinjection device as sold or dispatched. After the removing element isremoved from the device, access to the opening region is enabled, yetthe opening region is constrictable by the reducing piece, such thataccess into the opening region up to the needle is not possible.

In some preferred embodiments, the reducing piece can be moved into theopening region from a position in the injection device, e.g. proximallywith respect to the needle tip. The product container accommodated inthe injection device may comprise a portion which serves to accommodatethe product to be administered, wherein the reducing piece can be movedinto the opening region from a position which lies axially in the regionof the portion for accommodating the product to be administered. Theproduct container comprises a piston which can be moved in the portionfor accommodating the product to be administered, e.g. from a proximalposition to a distal position. This movement displaces the product anddelivers it through the needle. The portion for accommodating theproduct to be administered lies proximally with respect to the portionto which the needle can be or is fastened.

In some embodiments, the reducing piece may surround the productcontainer partially, e.g. in segments, and in some preferred embodimentsit surrounds the container annularly, for example in the region of theportion to which the needle is fastened. The reducing piece may form orcomprise a passage for the product container.

In some preferred embodiments, the product container can be providedwith a needle protecting cap in the injection device as dispatched,wherein the needle protecting cap is arranged on the portion to whichthe needle is fastened. The needle protecting cap protects the needleagainst contamination and keeps it sterile. The product container may beinserted into the injection device as a complete module together withthe needle protecting cap. The needle protecting cap may be made of aflexible material, such as a rubber-like material, or a firm materialsuch as hard plastic. The latter embodiment may be referred to as aso-called rigid needle shield. When the removing element and the needleprotecting cap are removed, the needle is exposed in the opening regionof the injection device, wherein the reducing piece can nonethelessprevent anyone pricking themselves.

In some preferred embodiments, the reducing piece can be fixed in aposition in the opening region, such as in a force fit and/or positivefit. An example of a force-fit connection would be clamping the reducingpiece in the opening region. An example of a positive-fit connectionwould be a latching connection in which the reducing piece or a part ofthe reducing piece latches into an element which surrounds the reducingpiece. To this end, in some embodiments the reducing piece can comprisecams or snappers which are elastically biased and latch into the elementsurrounding the reducing piece at the desired axial position in theopening region. The part which surrounds the reducing piece can compriseone or more recesses into which the reducing piece latches. The partwhich surrounds the reducing piece can be a housing, a triggeringelement or a needle protecting sleeve.

In some preferred embodiments, the opening of the reducing pieceexhibits a smaller cross-section than the opening region of theinjection device and a larger cross-section than a needle protecting caparranged on the product container and/or a portion for accommodating theproduct to be administered. This means that during assembly, at leastthe needle protecting cap of the product container—and, in otherembodiments, the portion for accommodating the product to beadministered—can be inserted through the opening of the reducing piece.

In some preferred embodiments, the reducing piece can be moved relativeto a housing, a needle protecting sleeve, a triggering element and/orthe needle. In some embodiments, the needle protecting sleeve can bemoved over the needle situated in the injection position to cover theneedle again after use. The reducing piece is slaved in the movement ofthe needle protecting sleeve, e.g. when the reducing piece has beenconnected axially fixed to the needle protecting sleeve. The triggeringelement serves to trigger the movement of the needle from its initialposition into its injection position. The triggering element can releasean energy storage means which shifts the needle, in some embodimentstogether with the product container. In some preferred embodiments, theneedle protecting sleeve can simultaneously perform the function of thetriggering element. The needle protecting sleeve which serves as thetriggering element can be shifted in the proximal direction relative tothe housing, for example by pressing the distal end of the needleprotecting sleeve onto the injection point. The needle protecting sleeveor the triggering element can protrude distally beyond the distal end ofthe housing, wherein when the injection device is pressed onto theinjection point, the needle protecting sleeve or the triggering elementis moved proximally into the housing. After the injection device hasbeen used, the needle protecting sleeve can protrude beyond the distalend of the housing to an extent which is greater than the extent towhich the needle protecting sleeve protrudes beyond the distal end ofthe housing before the injection is triggered.

Another aspect of the present invention, which can be both pursued inits own right and/or combined with other embodiments of the presentinvention, relates to an injection device for administering a productwhich comprises a product container for accommodating the product to beadministered. The product container comprises a tapering region orportion which connects distally to a portion for accommodating theproduct. This portion can be embodied to be hollow-cylindrical and/orcan shiftably accommodate a piston which can displace the product fromthe product container. The piston can be moved through the whole of theportion for accommodating the product. The proximal end of the productcontainer can comprise a projection which extends outwardly, e.g.radially, such as a flange.

In some embodiments, a fastening portion for the needle can connect orbe arranged distally with respect to the tapering region of the productcontainer. The fastening portion can be embodied such that a needle canbe attached to the product container and/or detached again from theproduct container. In some embodiments, the needle is fixedly arrangedon the fastening portion.

In some embodiments, the needle is exposed at least immediately beforeadministering. In the product container and/or injection device as soldand/or dispatched, the needle can be surrounded by the needle protectingcap which is fastened to the fastening portion for the needle, e.g. in aforce fit and/or positive fit, e.g. by being fitted on and/or by africtional fit. The needle protecting cap can be able to be completelyor at least partially removed from the product container to expose theneedle. The needle protecting cap can be a so-called rigid needle shieldor a simple rubber cap. In the case of a rigid needle shield, it may bepossible to remove only a part of the needle protecting cap to exposethe needle, wherein another part of the rigid needle shield remains onthe product container, e.g. on the fastening portion. The remaining partand removable part of the rigid needle shield can be connected by amaterial-fit or positive-fit connection, e.g. with a predeterminedbreaking point, which can be released by being destroyed.

In some embodiments, an injection device in accordance with the presentinvention comprises a movable holding member which can be moved from aposition in which it does not fulfil a holding function for the productcontainer to position in which it does fulfil a holding function for theproduct container. In some preferred embodiments, the holding member maybe moved distally to in front of a tapering region and/or a collar ofthe product container. The holding member can contact the productcontainer in the position in which it fulfils the holding function, butneed not, such that a gap can exist between the tapering region and theholding member as measured in the axial direction. If the holding membercontacts the product container, it can serve to divert a force exertedon the product container by removing the needle covering cap. If a gapexists between the holding member and the tapering region, the holdingmember can serve to prevent the product container from falling out ofthe injection device if the fastening device with which the productcontainer is normally accommodated in the injection device fails. Thefastening device can be embodied by a flange arranged on the proximalend of the product container and/or abutting the proximal end of aproduct container holder. If the flange should for whatever reasonbreak, the holding member prevents the container from falling out of theinjection device.

In some embodiments, the holding member can be shifted from a firstposition into the holding position. In the first position, the holdingmember can be situated laterally with respect to the product container,e.g. the portion for accommodating the product. In the first position,the holding member can be arranged such that the tapering region of theproduct container can be guided past the holding member. In somepreferred embodiments, the holding member can be guided at least inportions along the portion for accommodating a product.

In some embodiments, when moving into the holding position, the holdingmember can be able to perform a radial movement in relation to thelongitudinal axis of the product container. To this end, the holdingmember as a whole or in part can perform a radial movement. The holdingmember can be deformed, e.g. partially deformed, when it is moved intothe holding position. The deformation can be elastic and/or plastic. Insome embodiments, the holding member can be pivoted toward thelongitudinal axis.

In some preferred embodiments, an injection device in accordance withthe present invention comprises a means by which the holding member canperform a combined axial and radial movement when moving to the holdingposition. Such a means can, for example, be a part of a gear system, agear surface, a guiding rail, etc. For example, a gear surface can beprovided which forces the holding member toward the longitudinal axis ofthe product container during its axial movement. The gear surface canforce the holding member, e.g. shift and/or pivot and/or deform it, atleast partially or completely into the holding position.

In some embodiments, the means for deflecting the holding member, e.g.the gear surface, can be arranged or formed on an element whichsurrounds the product container. This element may be a product containerholder. The product container holder can form a passage for the productcontainer; e.g. it can be sleeve-shaped and surround the productcontainer. The holding member is arranged, e.g. radially, between theproduct container and the product container holder. The productcontainer holder can thus surround both the holding member and theproduct container. The holding member can be arranged such that it canbe moved relative to the product container and/or product containerholder when moving into the holding position. The product containerholder, the holding member, the product container and the housing of theinjection device can, for example, be arranged concentrically withrespect to each other.

In some embodiments, the distal end of the product container holder cancomprise an opening which allows a part of the product container to beinserted through it. The opening is large enough that the productcontainer, together with a needle protecting cap attached to it, can beinserted through it. The opening can, but need not, be large enough thatthe portion for accommodating the product to be administered would fitthrough the opening. The means for deflecting the holding member isarranged on the distal end of the product container holder which isformed over the circumference of the product container holder. The meansfor deflecting can comprise a surface which is inclined with respect tothe longitudinal axis.

In some embodiments, the holding member can surround the productcontainer over its circumference. The holding member can comprise anumber of tongues which can be moved to in front of the tapering regionof the product container by material deformation. In some preferredembodiments, the tongues can be meant when a holding member which can bemoved to in front of the tapering region of the product container ismentioned. This means that not all of the holding member but merely apart of the holding member need be able to be moved to in front of thetapering region. The holding member can comprise an annular base fromwhich the at least one tongue extends, e.g. in the direction of thelongitudinal axis.

In some embodiments, in the position in front of the tapering region ofthe product container, the holding member is or can be latched againstmoving any further relative to the product container. To this end, theat least one tongue or the annular base or another part of the holdingmember can comprise a latching element which engages with the partsurrounding the latching element, e.g. with the product containerholder. The latching element of the tongue can engage with thedeflecting means for the holding member and/or tongue.

In some embodiments, an injection device in accordance with the presentinvention can comprise at least one engaging member which is coupled ina force fit and/or positive fit to at least one of the reducing pieceand the holding member, thus enabling the reducing piece and/or holdingmember to be slaved in an axial movement of the at least one engagingmember. In some preferred embodiments, the at least one engaging membercan be moved in the distal direction. It can slave the engaging member,at least in portions, in this movement. To this end, the engaging membercan comprise links which extend from the annular base, e.g. in thelongitudinal direction and in the same direction as the at least onetongue. In some preferred embodiments, the at least one engaging membercan be moved in the distal direction and slaves the holding member, atleast in portions, in this movement, wherein no relative movement isperformed between the holding member and the at least one engagingmember in the course of slaving. To this end, the at least one engagingmember can engage with the at least one link of the holding member. Theholding member and the at least one engaging member can be movedtogether until the engaging member is moved in front of the productcontainer. It is possible for the at least one engaging member to movefurther relative to the holding member.

In some embodiments, when the holding member is moved, the reducingpiece can be moved along with it by being supported on the holdingmember. Alternatively or additionally, the reducing piece can be movedalong with the at least one engaging member, for example by the engagingmember engaging with it. In some preferred embodiments, the needleprotecting cap can be removed from the product container when the atleast one engaging member is moved in the distal direction, wherein thiscan be performed before, after or while the reducing piece and/orholding member is slaved.

In some embodiments, the at least one engaging member can be formed on aremoving element, e.g. a cap, on one or more arms which extend in thelongitudinal direction and mount the at least one engaging member,spring-elastically transverse to the longitudinal axis. The followingsteps can thus be performed when the removing element is removed fromthe injection device:

-   -   removing the needle protecting cap; and/or    -   slaving the holding member, such that its tongues are moved to        in front of the collar of the product container; and/or    -   slaving the reducing piece into a position in which it reduces        the cross-section of the opening region and thus prevents access        to the needle.

In some embodiments, an injection device in accordance with the presentinvention can comprise at least one of the following features:

-   -   a needle protecting sleeve which serves as a triggering element        for triggering an injection movement of a needle, wherein the        needle protecting sleeve can be shifted in the proximal        direction relative to the housing of the injection device to        trigger the injection movement and can be shifted in the distal        direction over the needle situated in the injection position;    -   an elasticity means, e.g. a spring, against which the triggering        element can be shifted for triggering and with which the        triggering element can be shifted in the distal direction over        the needle situated in the injection position;    -   a driven member which can be shifted in the distal direction by        a drive member, e.g. an advancing spring, to shift the product        container for an injection movement of the needle and/or to move        a piston in the product container for delivering product;    -   a blocking member which can be selectively engaged with the        driven member or the triggering element to prevent an axial        movement of the part with which the blocking member is engaged.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts two sub-assemblies of an embodiment of an injectiondevice in accordance with the present invention, before their finalassembly;

FIG. 2a depicts individual parts of the injection device, in aperspective view;

FIG. 2b is an enlarged view of three parts of the view from FIG. 2 a;

FIG. 2c is an arrangement of the three parts from FIG. 2b , as shippedor sold;

FIGS. 3a and 3b are longitudinal sectional views of an injection devicewith a removing element attached, wherein FIG. 3b is a view rotated by90° about the longitudinal axis in relation to FIG. 3 a;

FIGS. 4a and 4b are longitudinal sectional views of the injectiondevice, from which the removing element has been removed, in an initialstate, wherein FIG. 4b is a view rotated by 90° about the longitudinalaxis in relation to FIG. 4 a;

FIGS. 5a and 5b are longitudinal sectional views of the injection devicewhen triggered, wherein FIG. 5b is a view rotated by 90° about thelongitudinal axis in relation to FIG. 5 a;

FIGS. 6a and 6b are longitudinal sectional views of the injection devicein a state after an injection sequence and before a delivery sequence,wherein FIG. 6b is a view rotated by 90° about the longitudinal axis inrelation to FIG. 6 a;

FIGS. 7a and 7b are longitudinal sectional views of an injection deviceafter a delivery sequence, wherein FIG. 7b is a view rotated by 90°about the longitudinal axis in relation to FIG. 7a ; and

FIGS. 8a and 8b are longitudinal sectional views of an injection devicecomprising a needle protecting sleeve in a needle protecting position,wherein FIG. 8b is a view rotated by 90° about the longitudinal axis inrelation to FIG. 8 a.

DETAILED DESCRIPTION

With regard to fastening, mounting, attaching or connecting componentsof the present invention, unless specifically described as otherwise,conventional mechanical fasteners and methods may be used. Otherappropriate fastening or attachment methods include adhesives, weldingand soldering, the latter particularly with regard to the electricalsystem of the invention, if any. In embodiments with electrical featuresor components, suitable electrical components and circuitry, wires,wireless components, chips, boards, microprocessors, inputs, outputs,displays, control components, etc. may be used. Generally, unlessotherwise indicated, the materials for making embodiments of theinvention and/or components thereof may be selected from appropriatematerials such as metal, metallic alloys, ceramics, plastics, etc.Unless otherwise indicated specifically or by context, positional terms(e.g., up, down, front, rear, distal, proximal, etc.) are descriptivenot limiting. Same reference numbers are used to denote same parts orcomponents.

The individual parts of an injection device, which specifically form anauto-injector, shall firstly be described with reference to FIGS. 2a to2c . In the depicted embodiment, the injection device comprises: asleeve-shaped housing 1; a needle protecting sleeve 2 accommodated inthe housing 1 such that it can be longitudinally shifted andsimultaneously serves as a triggering element; a product container 5with a needle protecting cap 6 detachably fastened to it; a productcontainer holder 4 which accommodates the product container 5 andcomprises deflecting structure or means 4 a; a removing element 3 whichcomprises engaging members 3 a, 3 d; a drive member 8 in the form of ahelical spring which acts as a pressure spring and supplies the energyfor injection and delivery sequences; a driven member 7 which acts onthe product container 5; a holding element 10 which keeps the drivemember 8 tensed until the injection device is triggered and which isconnected axially fixed to the housing 1, snapped onto the housing 1;and a spring element 9 which supplies the energy for shifting the needleprotecting sleeve 2 to the needle protecting position. The injectiondevice also comprises a holding member 12 which allows easy assembly andcan nonetheless prevent the product container from falling out of theinjection device, and a reducing piece 11 which serves as an accessprotection to prevent anyone sticking or pricking themselves on thedevice. Of preferred embodiments, the one shown here includes both theholding member 12 and the reducing piece 11. In principle, the injectiondevice can be fitted with only one of these two parts.

FIG. 1 shows an auto-injector before its final assembly. When finallyassembled, the auto-injector is provided in two sub-assemblies, namely asub-assembly A which comprises the housing, the needle protecting sleeve2 and the drive unit, already biased, and a sub-assembly B whichcomprises the product container 5, the product container holder 4, theremoving element 3 and at least one of the holding member 12 and thereducing piece 11. This division into sub-assemblies has the advantagethat the sub-assemblies can be pre-assembled at a location other thanthe location at which the product container is finally assembled and/orintegrated. The sub-assembly A and the sub-assembly B minus the productcontainer can, for example, be supplied from a first facility to asecond facility, wherein at the second facility, the product container 5together with the needle protecting cap 6 is inserted with the needleprotecting cap 6 first into the product container holder 4 of acombination of the product container holder 4 and the removing element 3via an opening on the proximal end of the product container holder 4.The holding member 12 and the reducing piece 11 respectively comprise anopening (which may be thought of and/or referred to as comprisingelements 11 d, 12 d) which is large enough to insert the needleprotecting cap 6 of the product container 5 through. The holding member12 and the reducing piece 11 are respectively arranged in firstpositions and respectively shifted into second positions only once theremoving element 3 is removed from the injection device. This enablesthe product container 5 including the needle protecting cap 6 to beeasily integrated into the rest of the parts of the sub-assembly B.

The completely assembled sub-assembly B can then be inserted into thesub-assembly A via an opening on the distal end of the triggeringelement 2, where it is fastened to the housing 1, axially fixed butdetachably, by a fastening member 4 b of the product container holder 4which in this example is formed as a snapper. Another advantage of thedivision into sub-assemblies is that a multitude of sub-assemblies A andB can be supplied from the first facility to the second facility, and atthe second facility is a decision made as to which drug the injectiondevice is to be fitted with. This increases the ability of the injectiondevice to be flexibly used.

FIGS. 3a and 3b show the completely assembled injection device as soldand/or shipped or dispatched. Reference is additionally made to therepresentation of the individual parts in FIGS. 2a to 2c . The productcontainer 5 is shiftably mounted in the housing 1. The product container5 is accommodated in the product container holder 4 such that it cannotbe moved in the distal direction relative to the product containerholder 4. This is achieved by a finger flange 5 d which is formed on theproximal end of the product container 5 and protrudes radially outwardlyand acts on the proximal facing side of the product container holder 4.The reservoir part 5 a of the product container 5 accommodates theproduct to be administered. A piston 5 f is accommodated in thehollow-cylindrical reservoir part 5 a and abuts the inner wall of thereservoir part 5 a, forming a seal, and can be shifted in the directionof the needle 5 e relative to the reservoir part 5 a for deliveringproduct. The needle 5 e is non-detachably fastened to a fasteningportion 5 c of the product container 5. The fastening portion 5 cconnects distally to the reservoir part 5 a. The reservoir part 5 atransitions into the fastening portion by a collar 5 b. The collar 5 bthus forms a tapering region, at or in front of which at least a part ofthe holding member 12 is subsequently moved. To protect the needle 5 eagainst contamination and to keep it sterile, the needle protecting cap6 is arranged on the fastening portion 5 c and over the needle 5 e. Theneedle protecting cap 6 is fastened to the fastening portion 5 c of theproduct container 5 in a force fit and/or positive fit. Between thecollar 5 b of the product container 5 and the proximal end and/orproximal facing side of the needle protecting cap 6 there exists a gapwhich is at least large enough that at least one or both of the engagingmembers 3 a, 3 d and a part of the holding member 12 can engage with thegap.

The holding member 12 and the reducing piece 11 are shown in detail inFIGS. 2b and 2c . The reducing piece 11 comprises an annular base 11 c.The annular base 11 c comprises a passage or opening 11 d which isdimensioned such that the needle protecting cap 6 can be inserted and/ormoved through it, at least partially or completely. Conversely, theopening 11 d is dimensioned such that a human finger does not fitthrough it. The cross-section of the opening 11 d is smaller than thecross-section of the opening region 13 (FIG. 3a ), wherein thecross-section of the opening region is reduced by arranging the reducingpiece 11 in the opening region 13. The annular base 11 c also comprisescavities 11 a which are formed laterally with respect to the opening 11d as passages. The cavities 11 a can be separate from the opening 11 dor—as shown here—connected to the opening 11 d. Each of the cavities 11a serves as a passage for an arm 3 b which is formed on the at least oneengaging member 3 a, 3 d.

The reducing piece 11 comprises a number of projections which extend inthe proximal direction from the annular base 11 c and form abutments orlatching elements 11 e, 11 f for the same or different purposes. To thisend, the projections can be formed with equal or different lengths.

The latching element 11 e can, but need not, serve to abut the holdingmember 12, e.g. its annular base 12 c. The abutment means that when theholding member 12 is moved in the distal direction, the reducing piece11 is slaved by the holding member 12. If the latching element 11 e doesnot serve as an abutment, the reducing piece 11 can be slaved by the atleast one engaging member 3 a, 3 d.

The latching elements 11 e, 11 f latch, axially fixed, onto the needleprotecting sleeve 2 when the reducing piece 11 is situated in its secondposition, i.e. in the opening region 13. The reducing piece 11 is slavedin the movements of the needle protecting sleeve 2 due to it latching,axially fixed, onto the needle protecting sleeve 2. In the exampleshown, the reducing piece 11 comprises two latching elements 11 e andtwo latching elements 11 f, wherein the latching elements 11 e areformed on projections which are longer than the projections on which thelatching elements 11 f are formed. The latching elements 11 e can serveto block the axial movement in the distal direction, and the latchingelements 11 f can serve to block the movement of the reducing piece 11relative to the needle protecting sleeve 2 in the proximal direction.This means, as may be preferred, that the reducing piece 11 is connectedto the needle protecting sleeve 2 such that it cannot be moved in eitheraxial direction relative to the needle protecting sleeve 2.

The holding member 12 comprises an annular base 12 c from which tongues12 a and links 12 e project in the distal direction. The tongues 12 acan be deformed or bent toward the central or longitudinal axis of theholding member 12 flexibly, e.g. elastically or plastically. The tongues12 a i comprise a latching member 12 b on each of their distal ends,which can subsequently latch onto the deflecting means 4 a.

Each of the links 12 e comprises a groove 12 f which extends in thelongitudinal direction. The grooves serve to provide an engagement forengaging members 3 a or alternatively 3 d of the removing element 3. Thegrooves 12 f are continuous but could also be blind grooves. The arms 3b grip through the cavities 11 a of the reducing piece 11, such that theat least one engaging member 3 a can engage with the groove 12 f.

The annular base 12 c forms a passage or opening 12 d which is largeenough that the needle protecting cap 6 can be inserted or moved throughit. When not deformed, the latching members 12 b do not block thepassage for the needle protecting cap 6.

The deflecting means 4 a is arranged spring-elastically on the productcontainer holder 4, e.g. by an arm 4 g. This arrangement may facilitateassembly. As can be seen from FIG. 1, the product container 5 isinserted into the product container holder 4 which is exposed in thecircumferential direction. Since the product container holder 4 isexposed in the circumferential direction before the final assembly, thedeflecting means 4 a can spring away outwardlys and thus let the needleprotecting cap 6 through, without an increased assembly force beingnecessary or there being a danger of clamping. Because the cross-sectionis latterly reduced by the holding member 12, it is however possiblethat the deflecting means 4 a do not need to spring away, since thepassage for the needle protecting cap 6 is initially large enough. Thedeflecting means does not therefore necessarily need to be arrangedspring-elastically but can also be arranged rigidly. When the injectiondevice is finally assembled, as shown for example in FIGS. 3a and 3b ,the deflecting means 4 a cannot spring outwardly, since the productcontainer holder 4 is surrounded by the needle protecting sleeve 2,wherein the inner side of the needle protecting sleeve 2 forms a holdingportion 2 c which prevents the deflecting means 4 a from moving radiallyoutward.

The product container holder 4 comprises a fastening member 4 b, in theform of a cavity, which is directed outward, wherein the fasteningmember 4 b engages with a projection 1 a formed on the innercircumference of the housing and thus forms a positive-fit lock. Thislock can however be released while using the injection device. The lockmeans that the product container holder 4 is coupled, axially fixed, tothe housing 1, such that the product container 5 also cannot be moved inthe distal direction relative to the product container holder 4 due tothe engagement of the finger flange 5 d onto the proximal facing side ofthe product container holder 4.

The needle protecting sleeve 2 is guided on the inner circumference ofthe housing 1. The needle protecting sleeve 2 is situated radiallybetween the product container holder 4 and the housing 1. The needleprotecting sleeve 2 can in principle be shifted relative to the housing1, wherein in the injection device as dispatched, the needle protectingsleeve 2 is axially fixed relative to the housing 1. To this end, theneedle protecting sleeve 2 comprises an engaging member 2 a whichengages in a positive fit with an engaging counter member 1 b on theinner side of the housing 1. The engaging member 2 a isspring-elastically mounted and can be moved transverse to thelongitudinal axis of the injection device. The spring-elasticarrangement is formed by an arm, at the end of which the engaging member2 a is formed.

The removing element 3 at least partially seals the distal end of theinjection device. In some embodiments, the removing element 3 preventsaccess to the needle protecting sleeve 2 which protrudes beyond thedistal end of the housing 1. The removing element 3 is fastened to thehousing 1 in a force fit, by a sleeve-like continuation which surroundsthe distal end of the housing 1. Alternatively or additionally, theremoving element 3 can be fastened in a positive fit to the distal endof the injection device, such as for example to the housing 1 or theneedle protecting sleeve 2 or via the engagement between the engagingmember 3 a and the product container holder 4, e.g. its cavity 4 f. Theremoving element 3 also comprises a sleeve-shaped holding portion 3 cwhich in the injection device as dispatched is situated on the innercircumference of the needle protecting sleeve 2, axially level with theengaging member 2 a, to prevent the engaging member 2 a from movinginwardly, and thus ensures that the needle protecting sleeve 2 isprevented from moving relative to the housing 1 in the injection deviceas shipped, i.e. with the removing element 3 attached. It is thuspossible to reliably prevent the needle protecting sleeve 2 from beingmoved relative to the housing 1, such as for example when the injectiondevice is dropped and the needle protecting sleeve 2 would be movedrelative to the housing 1 due to mass inertia. The engaging member 2 athus serves to provide secure transport. The removing element 3 forms anannular gap between the outer sleeve which is fastened to thecircumference of the housing 1 and the inner sleeve which comprises theholding portion 3 c. When the removing element is attached, a part ofthe housing 1 and a part of the needle protecting sleeve 2 are situatedin the annular gap, also the engaging member 2 a and the engagingcounter member 1 b formed by the housing. The holding portion 3 c, e.g.its proximal end, also forms an assembly aid for pre-assembling thesub-assembly B, for example in that the reducing piece 11, e.g. theannular base 11 c, can be supported on the proximal end of the removingelement 3 and/or the holding portion 3 c, and at least one of theholding member 12 and the product container holder 4 can optionally besupported on the reducing piece 11.

At least one engaging member 3 a, 3 d is formed on the removing element3 and can be spring-elastically moved transverse to the longitudinalaxis of the injection device via the arm 3 b. While the sub-assembly Bis pre-assembled, and also in the injection device as dispatched, thecavity 4 f formed on the product container holder 4 is situated levelwith the engaging member 3 a in the longitudinal direction, such thatthe engaging member 3 a can spring radially outwardly into the cavity.When the product container 5 is inserted into the combination of theproduct container holder 4 and the removing element 3 while thesub-assembly B is assembled (FIG. 1), the engaging member 3 a springsinto the cavity 4 f when the needle protecting cap 6 passes the engagingmember 3 a. The engaging member 3 a also springs into the cavity 4 fwhen the product container 5 is completely inserted into the productcontainer holder 4, since in this case, the engaging member 3 a abutsthe distal end region and laterally abuts the reservoir part 5 a of theproduct container 5. Alternatively, the engaging member 3 a or anotherengaging member 3 d can engage with the gap between the needleprotecting cap 6 and the collar 5 b in this state. The engaging member 3a protrudes radially outward in relation to the outer circumference ofthe sleeve-shaped portion forming the holding portion 3 c and thus formsa gear surface, the function of which is described below.

The engaging member 3 d protrudes inwardly in relation to the innercircumference of the sleeve-shaped portion forming the holding portion 3c and is hook-shaped and dimensioned such that it can engage with thegap between the needle protecting cap 6 and the collar 5 b in the courseof using the injection device.

Since the engaging members 3 a, 3 d are arranged on approximately thesame axial position in the embodiments shown, they can form a commonengaging member. In principle, the engaging members 3 a and 3 d can bearranged on different axial positions.

The removing element 3 also comprises a projection which is directedradially outwardly and makes it easier for the user of the injectiondevice to grip the removing element 3 and apply an axial force to it.

When the product container 5 is completely inserted into the productcontainer holder 4, the projection 5 d can abut the proximal end of theproduct container holder 4 in the longitudinal direction.

The proximal end of the spring element 9 is supported on the holdingelement 10 and thus axially fixed with respect to the housing 1, and itsdistal end 9 is supported on the proximal end of the needle protectingsleeve 2. The spring element 9 is biased and charges the needleprotecting sleeve 2 with a force which acts in the distal direction,wherein the needle protecting sleeve 2 is blocked against moving in thedistal direction both in the initial position and immediately after theremoving element 3 is removed (FIGS. 4a and 4b ).

The holding element 10 seals the proximal end of the housing 1 and isconnected to the housing 1, e.g. snapped onto it, such that it isaxially and rotationally fixed. The holding element 10 could equally beformed integrally with the housing 1, wherein it is advantageous toconfigure the holding element 10 and the housing 1 in a number of parts,since this facilitates the ability of the individual parts to bemanufactured and facilitates assembling the injection device.

The holding element 10 comprises at least one—in this example,two—spring-elastic arms 10 b which extend in the longitudinal directionof the injection device and form a blocking member 10 a at their distalends. The blocking member 10 a can be moved transverse to thelongitudinal axis of the injection device. The blocking member 10 aforms an inwardly directed projection and an outwardly directedprojection in relation to the arm 10 b. The inwardly directed projectionengages in a positive fit onto with a collar 7 b formed by the drivenmember 7 and thus prevents the driven member 7 from being moved in thedistal direction. The outwardly directed projection of the blockingmember 10 a abuts an inwardly pointing surface of the needle protectingsleeve 2, such that the blocking member is held in engagement with thecollar 7 b and prevented from moving radially outward. The proximal endsof the arms 10 b are formed on a sleeve-shaped portion of the holdingelement 10.

The arm 10 b extends together with the sleeve-shaped portion of theholding element 10 over the entire length of a sleeve-shaped portion ofthe driven member 7. The arm 10 b, including the blocking member 10 aand the sleeve-shaped portion, is longer than the sleeve-shaped portionof the driven member 7. The drive member 8 is accommodated within thesleeve-shaped portion of the driven member 7 in the form of a biasedhelical pressure spring. The proximal end of the spring element 8 issupported on the holding element 10, and the distal end of the springelement 8 is supported on the distal end of the sleeve-shaped portion ofthe driven member 7, which simultaneously forms the collar 7 b. Two armswhich expand in the shape of a fork project from the distal end of thesleeve-shaped portion of the driven member 7 and respectively form acontact element 7 a at their distal end. The contact elements 7 acomprise bevelled surfaces which are flush with the housing wall of thereservoir part 5 a of the product container 5 in the longitudinaldirection. This means that the bevelled surfaces of the contact elements7 a enter into abutment with the proximal end of the product container 5when the driven member 7 moves in the distal direction.

In the following, the function or operation of an embodiment of aninjection device in accordance with the present invention is described.Starting from the injection device as dispatched, as shown in FIGS. 3aand 3b , the user of the device grasps the housing 1 with one hand andthe removing element 3 with the other hand. To remove the removingelement 3, the user pulls on the removing element 3, thus removing itfrom the housing 1. When the removing element 3 is removed, the engagingmembers 3 d are in or enter the gap between the needle protecting cap 6and the collar 5 b and ultimately enter into abutment with the proximalfacing side of the needle protecting cap 6. The engaging members 3 a arealso moved out of the cavities 4 f when the removing element 3 isremoved, but remain in the grooves 12 f. The engaging members 3 a, 3 dare ultimately prevented from moving radially outward by the inner side4 c of the product container holder 4, wherein the engaging members 3 dare even forced into the engagement with the gap and/or facing side ofthe needle protecting cap 6. To this end, the engaging member 3 a whichpoints radially outward forms a gear surface which slides off on theproduct container holder 4 when the engaging member 3 a moves out of thecavity 4 f and thus, with the aid of the holding portion formed by theinner side of the product container holder 4, ensures an engagementbetween the engaging member 3 d and the needle protecting cap 6. Whenthe removing movement of the removing element 3 is continued, theengaging members 3 d slave the needle protecting cap 6, thus removing itfrom the product container 5, and the engaging member 3 a latches out ofthe link 12 e or the groove 12 f, since the inward supporting effect forthe engaging member 3 a has been removed. The external force which isintroduced into the product container 5 by the removing movement can bediverted from the collars 5 b of the product container 5 onto theproduct container holder 4 via the deformed tongues 12 a and from theproduct container holder 4 into the housing 1 via the engagement 4 b.Alternatively or additionally, the external force can be diverted fromthe finger flange 5 d onto the product container holder 4 and from thereinto the housing 1 via the engagement 4 b. In the first alternative, theprojection 5 d of the product container 5 remains unstressed, thusavoiding damage to the product container 5. When the removing movementof the removing element 3 is continued, the engaging member 3 a whichhas latched out of the groove 12 f acts on the annular base 11 c andslaves the reducing piece 11. Removing the removing element 3 alsoenables the engaging member 2 a of the needle protecting sleeve 2 tomove inwards, since removing the removing element 3 also removes theholding portion 3 c.

The engagement between the engaging member 3 d and the needle protectingcap 6 additionally ensures that the engaging member 3 a remains in thegrooves 12 f. In the removing movement of the removing element 3, theengaging member 3 a abuts against the distal end of the groove 12 f. Theholding member 12 is slaved by the removing element 3. Due to theabutment between the latching element 11 e and the holding member 12,the reducing piece 11 is also slaved out of its first position which itassumes in the completely assembled injection device. When the holdingmember 12 is slaved and/or moved in the distal direction, the tongue 12a is deflected and/or deformed toward the longitudinal axis by thedeflecting means 4 a. The deformed tongue 12 a is then situated in frontof the collar 5 b, between the needle protecting cap 6 and the collar 5b. The deformed tongue 12 a latches onto the latching member 12 b whichprojects radially outward from the tongue 12 a, onto the deflectingmeans 4 a or onto the product container holder 4. The holding member 12is thus axially fixed relative to the product container holder 4.

The latching elements 11 e and 11 f of the reducing piece 11, which isslaved by the removing element 3 with the aid of the holding member 12and/or the engaging member 3 a, latches—axially fixed—onto the needleprotecting sleeve 2, as shown for example in FIGS. 4a and 4 b.

FIGS. 4a and 4b show the injection device from which the removingelement 3 has been removed. The device is then ready for use. To thisend, the user of the device grasps the housing 1 and presses the distalend of the injection device, which is formed by the needle protectingsleeve 2, onto the injection point. This slides the engaging member 2 aout of the engagement with the engaging counter member 1 b of thehousing 1, such that the engaging member 2 a is deflected inwardly. Arelative movement is performed between the needle protecting sleeve 2and the rest of the injection device, in which the needle protectingsleeve 2 is pushed over a gear surface 4 e of the product containerholder 4 which is embodied in the shape of a ramp, thus releasing theengagement between the product container 4 and the projection 1 a of thehousing 1, by deflecting the fastening member 4 b inward. When theneedle protecting sleeve 2 is shifted, the spring element 9 is alsotensed by the shifting distance and a cavity 2 d which is formed by theneedle protecting sleeve 2 is moved so as to be axially level with theblocking member 10 a. Inserting the needle protecting sleeve 2 triggersthe injection sequence and by extension also the delivery sequence. Theneedle protecting sleeve 2 can thus also be referred to as thetriggering element 2.

FIGS. 5a and 5b show the injection device in a state in which the needleprotecting sleeve 2 has been inserted for triggering. The fasteningmember 4 b is out of engagement with the engaging counter member 1 a,thus enabling it to move axially relative to the housing 1.

The blocking member 10 a can then be deflected into the cavity 2 d,wherein when it is in engagement with the needle protecting sleeve 2, itblocks or prevents a movement of the needle protecting sleeve 2 in thedistal direction. At the same time as it moves into the cavity 2 d, theblocking member 10 a releases the collar 7 b, such that the biased drivemember 8 can move the driven member 7 in the distal direction. Thesubsequently described part of an overall movement is referred to as theinjection sequence. In this movement, the contact elements 7 a enterinto abutment with the proximal end of the product container 5, thusshifting it in the distal direction until the needle 5 e protrudesthrough the opening 11 d beyond the distal end of the injection devicein accordance with the desired injection depth, as shown in FIGS. 6a and6b . As soon as the needle 5 e protrudes out of the distal end of theinjection device by the corresponding extent, a second fastening member4 d which is formed by the product container holder 4 abuts theprojection 1 a of the housing 1, thus stopping the advancing movement ofthe needle 5 e. The injection sequence is then complete.

Due to the bevelled surfaces of the contact elements 7 a and the forceof the drive member 8 which continues to act, the contact elements 7 aslide off on the proximal end of the product container 5, such that theyare deflected inwardly toward each other and/or into the reservoirportion 5 a, and thus enter into abutment with the piston 5 f. Thisstarts the delivery sequence, since the force of the drive member 8shifts the piston 5 f in the direction of the needle 5 e, such that thesubstance or product contained in the product container 5 is deliveredvia the needle 5 e.

FIGS. 7a and 7b show the injection device at the end of the product orsubstance delivery sequence, with the contact elements 7 a deflectedinto the reservoir part 5 a.

During the injection and delivery sequence, the sleeve-shaped portion ofthe driven member 7 prevents the blocking members 10 a from passing outof the engagement with the cavities 2 d of the triggering element 2. Atthe end of the product delivery sequence, the blocking members 10 a canbe moved out of the engagement with the cavity 2 d, since the drivenmember 7 has been moved completely past the blocking members 10 a.

Once the user removes the injection device from the injection point afew seconds after the product delivery sequence is complete, the springelement 9 presses the needle protecting sleeve 2 in the distaldirection, wherein the blocking members 10 a are moved out of theengagement with the cavities 2 d. The needle protecting sleeve 2 is alsoshifted over the distal end of the needle 5 e together with the reducingpiece 11, as shown in FIGS. 8a and 8 b.

To prevent the needle protecting sleeve 2 from being pushed back intothe housing 1, the needle protecting sleeve 2 comprises a blockingmember 2 c which engages with the projection 1 c of the housing 1 in apositive fit, e.g. such that it cannot be released, and/or such that itcan only be released by extreme force and/or by being destroyed. It isthus no longer possible under normal circumstances to push the needleprotecting sleeve 2 back into the housing 1. It is also not possible toinsert a finger into the distal end of the injection device due to thesize or dimension, e.g. cross-section, of the opening region 13 beingreduced by the reducing piece 11. The danger of injury as a result ofusing the device is thus reduced.

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. The embodiments were chosen anddescribed to illustrate the principles of the invention and thepractical application thereof, and to enable one of ordinary skill inthe art to utilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated. All suchmodifications and variations are within the scope of the invention asdetermined by the appended claims when interpreted in accordance withthe breadth they are fairly, legally, and equitably entitled.

What is claimed is:
 1. An injection device for administering a product,comprising: a sleeve shaped housing; a product container holderaccommodating a product container; a drive member that supplies energyfor product delivery; a driven member comprising a sleeve-shaped portionand acting on the product container; a holding element that keeps thedrive member tensed until the injection device is triggered and thatcomprises at least one spring elastic arm extending in a longitudinaldirection of the injection device and forming a blocking member at itsdistal end, and a needle protecting sleeve guided on an innercircumference of the sleeve shaped housing, and shiftable relative tothe housing in the proximal direction, wherein, during an injection anddelivery sequence, the sleeve-shaped portion of the driven memberprevents the blocking member from passing out of an engagement with acavity of a triggering element, into which the blocking member has beendeflected after the needle protecting sleeve has been inserted forinjection triggering.
 2. The injection device according to claim 1,wherein the holding element is connected to and axially fixed to thehousing or formed integrally with the housing.
 3. The injection deviceaccording to claim 1, wherein the holding element seals the proximal endof the housing and is connected to the housing such that it is axiallyand rotationally fixed.
 4. The injection device according to claim 1,wherein the drive member acts as a pressure spring and is accommodatedwithin the sleeve-shaped portion of the driven member.
 5. The injectiondevice according to claim 4, wherein the drive member is accommodatedwithin the sleeve-shaped portion of the driven member in the form of abiased helical pressure spring.
 6. The injection device according toclaim 5, wherein the proximal end of the helical spring is supported onthe holding element and the distal end of the helical spring issupported on the distal end of the sleeve-shaped portion of the drivenmember.
 7. The injection device according to claim 1, wherein theblocking member is movable transverse to the longitudinal axis of theinjection device.
 8. The injection device according to claim 1, whereinthe blocking member comprises an inwardly directed projection and anoutwardly directed projection in relation to the at least one arm, andwherein the inwardly directed projection engages the driven member toprevent the driven member from being moved in the distal direction. 9.The injection device according to claim 1, wherein the proximal ends ofthe at least one arm are formed on a sleeve-shaped portion of theholding element.
 10. The injection device according to claim 1, whereina shifter spring element supplies energy for shifting the needleprotecting sleeve to the needle protecting position.
 11. The injectiondevice according to claim 1, wherein the holding member comprises anannular base and is axially fixed by latching members of the holdingmember at a distal end of the product container holder to prevent theproduct container from falling out of the injection device.
 12. Theinjection device according to claim 1, further comprising a removingelement that at least partially seals a distal end of the injectiondevice.
 13. The injection device according to claim 1, furthercomprising a removing element fastened to a distal end of the injectiondevice to prevent access to the needle protecting sleeve which protrudesbeyond the distal end of the housing.
 14. The injection device accordingto claim 13, wherein the removing element is fastened to the housing ina force fit, by a sleeve-like continuation which surrounds the distalend of the housing.
 15. The injection device according to claim 13,wherein the removing element is fastened in a positive fit to the distalend of the injection device.
 16. The injection device according to claim13, wherein the removing element is fastened to the housing or theneedle protecting sleeve or via the engagement between an engagingmember of the removing element and the product container holder.
 17. Theinjection device according to claim 13, wherein the removing elementcomprises a sleeve-shaped holding portion which in the injection deviceas dispatched is situated on the inner circumference of the needleprotecting sleeve axially level with an engaging member of the needleprotecting sleeve, to prevent the engaging member from moving inwardly,thereby to prevent the needle protecting sleeve from moving relative tothe housing in the injection device as shipped or if dropped.